A Phase II Study of Pulse Reduced Dose Rate Radiation Therapy With Bevacizumab

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT01743950
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    10mg/kg every 2weeks.
  • PRDR — RADIATION
    Daily dose of 2.0gy delivered in .2gy pulses for a total of 54gy over 5.5 weeks and 27 fractions. In the rare instance of the presence of extensive disease requiring essentially whole brain radiation, a total daily dose of 1.8 Gy delivered in .2 Gy pulses for 23 fractions to a total dose of 41.4 Gy will be utilized.

Study Details

To determine the efficacy of Pulse Reduced Dose Rate (PRDR) radiation when given in 27 fraction over 5.5 weeks with concurrent bevacizumab followed by adjuvant bevacizumab until time of progression in patients with recurrent high grade gliomas (grade III and grade IV). Patients will be placed in 1 of 4 groups based on their histologic diagnosis and prior exposure to bevacizumab.

Key Dates

First listed
Dec 6, 2012
Start date
Dec 3, 2012
Status verified
Jan 2026
Primary completion
Dec 24, 2024
Completion
Dec 24, 2024

Study Design

Enrollment
49 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Bevacizumab-naïve with recurrent IDH wildtype high grade glioma
    27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
  • Active Comparator: Bevacizumab-exposed with refractory recurrent IDH wildtype high grade glioma
    27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
  • Active Comparator: Bevacizumab-naïve with recurrent IDH mutant glioma
    27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
  • Active Comparator: Bevacizumab-exposed with recurrent IDH mutant glioma
    27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression

Primary Outcome Measure

Overall Survival [ Time Frame: estimated to be an average of 12 months (the estimated mean follow-up time) ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Wisconsin Hospital and ClinicsMadisonWisconsin53792-

Find similar trials in Madison, WI

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
University of Wisconsin Hospital and Clinics· Madison, WI

Related Studies